Department reassures patients, public on the recall of Enalapril 10 mg tablets
The Department of Health wishes to reassure patients, healthcare professionals and the general public that the recent recall of Enalapril 10 mg tablets - medication used to treat high blood pressure and manage heart failure, does not affect the same product packaged at 5 mg which is currently being supplied to public sector health facilities.
The recall of certain batches of Enalapril 10 mg tablets by the South African Health Products Regulatory Authority (SAHPRA) applies specifically to Enalapril 10 mg tablets supplied by Arya Pharma.
The affected tablets (Enalapril 10 mg) were only approved as a temporary alternative while the contracted supplier, Austell Pharmaceuticals, experienced a delay in releasing its Enalapril 5 mg product following quality checks by the SAHPRA.
Thus, the Department has confirmed with SAHPRA that the Enalapril Arya 5 mg tablets may be used and distributed in the country, and all batches supplied to the public health sector have been confirmed to meet the required quality and registration standards. Patients using Enalapril 5 mg tablets do not need to stop taking this life-saving medicine mainly because of the recall of the 10 mg tablets.
Patients should continue taking their medicine as prescribed unless advised otherwise by their healthcare professional. Healthcare professionals are also advised to continue prescribing and dispensing Enalapril 5 mg tablets in line with existing clinical protocols.
The Department has requested that provinces and healthcare facilities share this information with healthcare professionals and other relevant stakeholders to avoid unnecessary concern or disruption to patients.
For more information and media enquiries, please contact:
Mr Foster Mohale
Departmental Spokesperson
Cell: 072 432 3792
E-mail: Foster.mohale@health.gov.za
Mr Sello Lediga
Health Ministry Spokesperson
Cell: 082 353 9859
E-mail: Sello.Lediga@health.gov.za
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